The following data is part of a premarket notification filed by J&j Corporate Biomaterials Center with the FDA for Afb (absorbable Foam Buttress).
| Device ID | K014183 |
| 510k Number | K014183 |
| Device Name: | AFB (ABSORBABLE FOAM BUTTRESS) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | J&J CORPORATE BIOMATERIALS CENTER RT. 22 WEST, P.O. BOX 151 Someville, NJ 08876 -0151 |
| Contact | David A Dalessandro |
| Correspondent | David A Dalessandro J&J CORPORATE BIOMATERIALS CENTER RT. 22 WEST, P.O. BOX 151 Someville, NJ 08876 -0151 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-20 |
| Decision Date | 2002-06-12 |
| Summary: | summary |